Surgical method and auxiliary device to correct penis curvature

ABSTRACT

The invention refers to a surgical method to correct penis curvature, as well as a method to determine the location of the main incision line, method to determine the geometrical distribution and size of forked ends of the main incision line and a method to determine dimensions of a defect, being all methods geometrical and auxiliary to a surgical intervention to correct penis curvature. Furthermore, the invention also refers to an auxiliary device for the surgery to correct penis curvature.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is an U.S. national phase application under 35 U.S.C.§371 based upon co-pending International Application No.PCT/BR2003/000050 filed on Mar. 31 , 2003. Additionally, this U.S.national phase application claims the benefit of priority of co-pendingInternational Application No. PCT/BR2003/000050 filed on Mar. 31, 2003.The entire disclosures of the prior applications are incorporated hereinby reference. The international application was published on Oct. 14,2004 under Publication No. WO 2004/086981 A1.

FIELD OF THE INVENTION

The invention refers to a surgical method, as well as a method determinethe location of the main incision line, method determine the geometricaldistribution and size of forked ends of the main incision line and amethod determine the defect dimensions, being all methods geometricaland auxiliary for a surgical intervention to correct penis curvature.Furthermore, the invention also refers to an auxiliary device to thevarious methods.

More specifically, the invention refers to a surgical method with thepurpose to correct penis curvature, being it inborn or acquired as inPeyronie's disease, and additional methods used during said surgery, asfollows:

-   -   to accurately determining the location of the main incision        line;    -   determine the distribution and size of the main incision line's        forked ends; and    -   determine the dimensions of the defect to which a graft will be        applied; as well as an auxiliary device to said methods.

BACKGROUND OF THE INVENTION

Irregular penis curvature while erected may be inborn or of acquiredorigin. In the latter case, it is called Peyronie's disease, as areference to the French physician who discovered it.

Penis structure is formed by a tissue recovering the corpora cavernosacalled tunica albuginea. On the other hand, elastic fibers integratingthe tunica albuginea form an irregular framework on which collagenousfibers lie. These two structural components are essential to penisconfiguration during erection, as they allow the increase of penisdiameter and extension during tumescence. Any defect on collagenous andresilient fibers of the tunica albuginea can lead to significant changesin erection hemodynamics. Erection hemodynamics means, in thisapplication, the movement with which blood runs around the corporacavernosa in the penis erection process.

The tunica albuginea performs an essential role in erection due to itsflexibility and stiffness characteristics. The pPenis maximum length,width and curvature while in erection are determinedby the configurationof the tunica albuginea.

In case of an inborn curved penis, the problem is caused by lack offlexibility of the tunica albuginea and/or its covers. On the otherhand, Peyronie's disease is characterized by developing cicatricialtissue on said tunica albuginea, reducing its flexibility.

During erection, the normal side of the penis, the flexibility of whichis preserved, presents the usual gain in size, while the affected size,due to a loss in flexibility of the tunica albuginea and/or itscovering, does not expand equally, with a consequent curvature towardsthe same size and loss of penis functional size.

Not only the functional size of the penis is reduced but also, in moresevere cases, sexual act practice by man is hidered, keeping him fromhaving a normal life.

Currently existing techniques to correct penis curvature basicallyconsist of (1) reducing the long side of the penis to the size of theshort side, or (2) increase the short side of the penis to the same sizeof the long side.

When the reduction of the long side of the penis to the size of theshort side is desired, the following is done: (1) elliptical excision onthe tunica albuginea on the opposed side of the penis to that one withthe defect, subsequently suturing borders; (2) plication or pleat of thetunica albuginea on the opposed side to that one with the defect, toreduce the long side not resorting, however, to an incision or resectionof the tunica albuginea; or (3) lengthwise incision on the longer sidefollowed by crosswise suture.

Said techniques incur a few disadvantages. Firstly, while reducing thelong side to the size of the short side, curvature can be corrected, butthe patient will be dissatisfied with the reduction of the size of thepenis, which will be as extensive as the existing curvature. Therefore,patients are reluctant to accept to accept this kind of surgicalprocedure. Another disadvantage consists in the fact that theapplication of said skills do not include an exact determination of theexcision place and the size of the ellipse to be taken off or the placeand size of lengthwise plication(s), or incision(s) and crosswisesuture.

As previously shown, other skills extend the short size of the penis tothe same size of the long side. These surgical procedures are made byincision and/or excision of the tunica albuginea by making use of graftsto cover the side which will become longer after being submitted tosurgery.

Procedures to extend the short side of the penis overcome thedisadvantage of reducing the size of the penis, but incur in otherproblems as described below.

In about 70% of Peyronie's disease cases, the plate of cicatricialtissue is palpable. At the time of the surgery, the surgeon can feel theplate of cicatricial tissue and determining the place where incision orexcision will be made. In 30% of cases, there is no palpable cicatricialtissue during surgery. It is possible that the tunica albuginea is lessflexible without alteration of it thickness so as not to be palpable,and it is also known that there are flexibility changes in the tunicafarther from the plate, thus explaining cases in which the substitutionof plate(s) do not correct penis deformation. Furthermore, there arepatients presenting multifocus plates.

Due to the above, surgeries based on cicatricial tissue plates do solveall cases and may not correct penis curvature with its single removal,since the flexibility of the tunica is compromised at a distance of theplate(s).

Therefore, the procedure of excision of plate(s) by itself may not besufficient to correct penis curvature, and complementary relaxationincisions must be added.

Since the patient's main claim is the penis deformation (and not theplate, when present), it is possible to correct it with the singleincision or relaxation incisions (correction by expansion, instead ofsubstitution). By means of a linear incision, it is possible to create asimpler defect on the tunica albuginea, which will be covered by agraft, facilitating the suture procedure.

Another disadvantage of the excision and graft procedures is the highrate of post-surgery erectile dysfunction which, in various studies ofthe state of the art, are reported as varying between 12% and 100%(Dalkin, B. L.; Carter, M. F., Venogenic Impotence following dermalgraft repair for Peyronie's disease, J. Urol., v. 146 (3), p. 849-51,1991).

Currently, no matter the method to correct penis curvature, moreaccurate means determine correction are not employed.

When the increase of the short side of the penis is desired withconsequent graft application, there is also no accurate proceduredetermine the dimensions of said defect of the tunica and thecorresponding graft. Techniques measure the defect on the tunica withthe penis in a flaccid state, under traction, which is not coincidentwith the defect required to correct the deformity, which is related tothe stretched tunica during erection.

Furthermore, for all previously shown surgical skills, it is necessaryto keep the penis erect to visualize and determining the location of theincision line, even if there is no accurate method for that. Currently,erection is forced by continuous serum injection within the corporacavernosa. This injection is made by means of two needle syringescontaining serum applied within corpora cavernosa. The problem to effectsaid practice is the need for the assistants to make the injection and,since there is much serum leakage, the syringe needs to be changed tofill it again with serum. Therefore, the penis will again become flaccidand a new erection will have to be induced determine incision locations.According to one of the alternatives of the invention, the use of aninfusion pump allows an stable erection under maximum rigidity,providing a surgery with optimized results.

The invention aims to solve the problems as found in the prior art.

More specifically, an object of the invention is a surgical method tocorrect penis curvature.

Furthermore, another object of the invention is a geometrical method toaccurately determining the most appropriate location of the mainincision line to be made in a surgery to correct penis curvature.

Another object of the invention is a geometrical method to accuratelydetermining distribution and the size of the forked ends of the mainincision line to be made in a surgery to correct penis curvature.

Another object of the invention is a geometrical method to accuratelydetermining the dimensions of the defect created by the surgery tocorrect penis curvature when the shorter side of the penis should beextended, aiming at introducing a graft.

One further object of the invention is an auxiliary device to thesurgery to correct penis curvature based on the geometrical methods ofthe invention.

SHORT DESCRIPTION OF THE INVENTION

To solve deficiencies found in the prior art, we have developed asurgical method to correct penis curvature, geometrical methods (1) toaccurately determining the location of the main incision line, (2)determine the distribution and size of the forked ends of said incision,as well as (3) determine the dimensions of the defect created on thetunica during a surgery to correct penis curvature, due to theintroduction of graft. The invention also refers to an auxiliary deviceto realize its methods.

In a first aspect, the invention deals with a method to accuratelydetermining the location of the main incision line in a surgery tocorrect penis curvature, which comprises the following steps:

a. inducing and keeping the penis erect;

b. determining a line along the central penis axis;

c. determining a tangential line to each one of the two substantiallystraight segments adjacent to the penis curvature to be corrected;

d. determining the bisectrix on the intersection of said two tangentiallines; and

e. determining the main incision line, whose direction coincides withthe bisectrix direction.

It is important to mention that the invention does not involve the usualsurgical practice regarding e.g. incisions themselves, patient'sanesthesia, adaptation or asepsis of the surgical environment,appropriate surgical instruments, etc. These are aspects which the oneskilled in the art is entitled to apply as conveniently as possible.

The method of the invention, in a first alternative, consists firstly ofinducing and keeping penile erection. Erection may be induced by seruminjection under pressure within the penis' corpora cavernosa.

In a particular embodiment of the invention, a pump is used,particularly an infusion pump, for continuous serum injection. Thisavoids the handling of syringes and variation in serum supply, allowingthe penis to remain erect as appropriately as possible to best make thesurgery, i.e. under continuous maximum erection, during the whole timerequired to apply the method.

After the erection is obtained, a line is determinedand optionallydrafted in coincidence with the central penis axis, following itscurvature. The central line is drafted over the imaginary plan (referredto below as working plan) containing both substantially straightsegments of the penis adjacent to the curvature to be corrected, i.e. afirst segment before the curve and a second segment after the curve.

The following path consists in determining tangential lines to both saidstraight segments over the working plan. In case there is one singlecurvature to be corrected by surgery, a tangential line to the firstsegment is drafted from the base of the penis towards the glans; anothertangential line to the second segment is drafted, starting from theglans towards the base. Said tangential lines may be drafted withreference to the central penis axis or with reference to the higher andlower lines, limiting the lateral penis surfaces over the working plan.

The intersection point of both tangential lines giving origin to thebisectrix line formed between both tangents determinings the maximumpenis curvature region. A crosswise line around the penis body or tunicaalbuginea is determinedby following the bisectrix line direction. Saidline is circumferential to the penis body, indicating the direction ofthe main incision. The extension of the main incision line optionallydoes not intercept both insertions of the intercavernosum septum, notexcluding, however, any other configuration.

Within this first aspect of the invention, the bisectrix linedeterminings in a substantially accurate way the direction of the mainincision, since this is the most appropriate region to correct thedefect causing penis curvature. Guided by that line, the physician makesa main incision partially surrounding the penis body, long enough tobreak force lines present in the curvature, e.g. in case of increasingthe shorter side of the penis. “To break force lines”, as used herein,means to eliminate tensions favoring or tending to allow the curvatureto be corrected to remain.

In a second aspect, the invention deals with a method determine thegeometrical distribution and size of the terminals in a V-incision oneach one of the ends of the main incision line in a surgery to correctpenis curvature. From a surgical point of view, it is not only importantdetermine in a substantially accurate way the location of the mainincision line to be assured that the defect is being corrected asappropriately as possible, but it is also required that the distributionand size of forked ends on the ends of the main incision line areappropriately determinedfor the graft anchoring over the generateddefect to be efficient, defect and graft having simpler configurations,thus facilitating the suture procedure.

It is not an object of the invention determine which is the best formatto be used for said incision, but to provide means determine thegeometrical distribution and size of the V-incision to effectively helpto correct penis curvature. The method of the invention assumes that themain incision line surrounding the patient's penis as an incompletecircumference, following the orientation of the previouslydeterminedbisectrix line, has already been drafted or the guidingincision has also been made by the surgeon (preferably not reachingcorpora cavernosa to avoid loss of erection, by way of leakage ofserum).

The invention therefore also deals with a method determine thegeometrical distribution and dimension of forked ends of an incision, ofan angle α between said terminals, in a surgery to correct peniscurvature, comprising the following steps, which are additional andsubsequent to those of the already described method determine thelocation of the main incision line:

f. determining two perpendicular lines respectively to said tangentiallines, not crossing the penis curvature region; each one of thempreferably crosses said perpendicular line in one point where saidtangential lines to the central penis axis start to separate from it;

g. determining the difference (C) between the extension of the longerside and the extension of the shorter side of the penis, between saidperpendicular lines, over the working plan;

h. determining a line which is perpendicular to the main incision line,crossing it at a point (G), as large as said difference (C), of ends (F)and (F′), equally distant from the bisectrix;

i. determining the dimension of a segment (S), so that:S=tg(90−α/2).C/2

in which α is the desired angle between both ends on the fork of themain incision line and (C) is the previously mentioned difference.

j. determining the location of a point (E), distant from the point (G)the value of extension of said segment (S) along the main incision line;

k. link the point E to the points (F) and (F′), so to obtain thedistribution of forking ends under the desired geometry, with a sizedeterminedby the distance between points (E) and (F), or (E) and (F′).

The end point (G) of the main incision line as described above isopposed to an end point (G′) on the opposed end of the same line. Forkedends may therefore be made as described above on each one of the ends ofthe main incision line.

Perpendicular lines as mentioned on step (f) above may be drafted bypassing through any point of the central penis axis which do not lie onthe penis curvature region since, no matter which is its location, theyallow to detect the dimensional difference between both sides of thecurved penis, one longer and another shorter one. Particularly, saidperpendicular lines can be drafted as equally distant from thebisectrix, not excluding any other option.

After the perpendicular lines to the tangential lines are drafted, theextension of C is determinedbetween both curved segments composing thelonger and shorter lateral lines of the penis body or the tunicaalbuginea, over he working plan. The length difference between these twosegments substantially corresponds to the size difference between thelonger and shorter sides of the penis, substantially determining therequired distribution and size of required and enough incisions for theforked ends of the main incision, generating a controlled defect in thesurgery to increase the shorter side of the penis.

The difference (C) is used for the corrective surgery to reduce thelonger side of the penis, by subtracting said extension (C) from thedimension of the longer side of the penis. The reduction can be made bymeans of (1) plication or pleat and/or (2) excision and suture, and/or(3) lengthwise incision and crosswise suture. Said procedures, alone orcombined among them in any way, may be applied to one single region overthe curvature region or to more than one region over the curvatureregion, as long as the dimension (C) corresponds to the total extensionto be reduced.

The method can be employed for any angle α of the V-incision,advantageously between 60° and 180°, particularly between 90° and 150°and, most particularly, about 120°.

One further aspect of the invention consists of a method determine thedimensions of a defect to be filled in by a graft, when the elongationof the short side of the penis is desired for a surgery to correct itscurvature. To obtain a rectangular defect, the method basicallycomprises the steps of:

a. determining the extension of the main incision line between points(G) and (G′), as per the step (j) of the process as described furtherabove, representing the length (L) of said defect;

b. determining the difference (C) between the extension of the longerside and the extension of the shorter side of the penis, between saidperpendicular lines, over the working plan; as per the step (g) of themethod as described further above, representing the width of saiddefect.

The method can optionally comprise the following additional steps:

c. proportionally increasing, if necessary, the length L and width (C)measurements of the defect, from the steps (a) and (b) above, if thegrafting material to be used presents contraction;

d. transporting and drafting the length and width measurements of thedefect, from the steps (a) and (b) above, with the optional correctionof (c) over the grafting material (e.g. bovine pericardium or dermis).

In the method determine the dimensions of the rectangular defect, points(E) and (E′) of the main incision line are optionally located in theregion of the longer side of the curved penis, but not excluding anyother embodiment.

To obtain a trapezoidal defect which is appropriate for lateralcorrection cases, or a predominantly lateral curvature, the methodbasically comprises the following steps:

a. determining the extension of the main incision line between the endpoints (G) and (G′), as per the step (j) of the process as describedfurther above, representing the length (L) of said defect;

b. determining the difference (C) between the extension of the longerside and the extension of the shorter side of the penis, between saidperpendicular lines, over the working plan; as per the step (g) of theprocess as described further above;

c. determining the dimension of the shorter base D of the trapeziumbetween about 10% and about 50% of the (C) value;

d. determining the dimension of the longer base of the trapezium betweenabout 110% and about 150% of the (C) value. C and D are typically summedup.

The method can optionally comprise the following additional steps:

e. proportionally increasing, if necessary, the measurements from thesteps (a), (c) and (d) above if the grafting material to be usedpresents contraction;

f. transporting the measurements from steps (a), (c) and (d),respectively defining height, longer base and shorter base of thetrapezoidal shape of the generated defect, with the optional correctionof step (e) over the grafting material.

In the method determine the dimensions of the trapezoidal defect, endpoints (E) and (E′) of the main incision line are particularly locatedso that its path does not cross both insertions of the intracavernosumseptum.

In one more aspect, the invention deals with a surgical method tocorrect penis curvature, which comprises the following steps:

a—geometrically determining the location of the main incision linecrosswise to the central penis axis, so that it is located over themaximum curved region to be corrected.

b—to correct the curvature by increasing the shorter side of the penis:

b1—geometrically determining the desired distribution and size of theforked ends of the main incision line;

b2—geometrically determining the size of the defect created by theincision on the main line and the forked ends;

b3—effecting the main incision and the incision of the forked ends,generating a defect;

b4—implant the graft over said defect, substantially coincident with thedefect, optionally with corrected dimensions, bearing in mind thecontraction of the grafting material;

c—to correct the curvature by reducing the longer side of the penis, thelonger side is reduced in the curvature region by means of one or moreof the following skills as applied over one or more places within thecurvature region:

c1—plication or pleat; and/or

c2—excision and suture; and/or

c3—lengthwise incision and crosswise suture.

In its various aspects, the invention is also applied to surgeries tocorrect penis curvature by reducing the longer side of the penis, oreven when it is chosen to simultaneously partially reduce the longerside of the penis and partially increase the shorter side of the penis.

In one more aspect, the invention deals with a device developed to helpthe realization of the above described methods.

Said device comprises:

a. two longer rules linked together by a junction and adjustable betweenthem along a hypothetical plan containing them, having rotation and/ortranslation between one and the other;

b. a flexible measurement element connected to said junction of the twolonger rules;

c. two shorter rules, each one respectively fixed to one of said longerrules, perpendicularly to them, which are able to move in translationalong their lengths.

d. optionally, elements to non-permanently clamp the device to the penisor to portions of it—e.g. clamps or staples.

e. a second optional device comprising the above elements, associated tothe first device and substantially parallel to it.

Both longer rules are associated by any appropriate means of junction,such as a fixing pin allowing a rule to both rotate with relation to theother and also to run alongside the other, e.g. by means of railsassociated to them. Due to this characteristic, both longer rules canassume any position with relation to each other, along a hypotheticalplan containing them.

Optionally, the device is provided with a clamping element allowing tonon-permanently fix the position of one rule regarding the other.

Associated to said junction, e.g. a fixing pin, there is also a flexiblemeasurement element, such as a flexible ribbon with measuring markswhich can rotate over the same plan of said both longer rules. In aparticular embodiment of the invention, the fixing pin comprises twoconcentric axes. One of them is fixed to one of the longer rules and theother one is fixed to the measurement ribbon. On each concentric axis,there is a mark similar to a protractor, in which one can easilyvisualize e.g. (1) the angle between the rule and the measurement ribbonand therefore determining the average angle between both rules, and (2)the angle between both measurement rules, so determine the curvaturegrade to be surgically corrected.

The device also comprises two shorter rules, each one fixed to one ofsaid longer rules. The shorter rules stay in perpendicular position tolonger rules, are optionally flexible and can run along the length ofsaid longer rules, e.g. by means of the same rails of longer rules.

With the help of the device, it is possible to employ the invention todetermine in a substantially accurate way the location of the mainincision line, distribution and size of its forked ends, and defect andgraft dimensions.

With the help of the longer rules, tangential lines to the central penisaxis line are located or drafted. The central penis line can optionallyalso be drafted, if interesting for visualization. Drawing of tangentiallines can be made at any point of penis straight segments, as long asover the working plan. This means that one can draw perpendicular lineson both the lower side of the penis and on the middle of its body, oreven on the higher side of the penis, since the determination of thebisectrix is independent from the horizontal position of the device.

By putting the device closer to the penis, one can attach a rule to thepenis to draw the first tangential line. The other rule is adjusted tothe working plan to draw the second tangential line, eventually alsoattaching it to the penis. Tangential lines can be drawn according torule orientation, by any appropriate means, be it a pen, a toothpickdipped into methylene blue or any other.

After tangential lines are drawn, the bisectrix line is drawn with thehelp of the central measurement ribbon. The central measurement ribbonis adjusted so to remain in an average angle between both longerrules—e.g. by means of the central pin as already mentioned, providedwith two concentric axes with marks allowing the determination of themean angle between both longer rules, which determines the bisectrix ofintersection of both rules.

Since the measurement ribbon is flexible, it can be bent over the bodyof the penis. In a preferred embodiment of the invention, themeasurement ribbon has a central tear through which it is possible todraw with appropriate accuracy the bisectrix line around the penis.Particularly, the central tear is between 1 mm and 5 mm wide.

With the help of the two shorter rules, it is possible to drawperpendicular lines to the tangential lines, determine the difference insize between the longer and shorter sides of the penis along the workingplan. It is possible to put the shorter rules nearer or farther from thebisectrix, visually verifying its location with relation to the regionswhere penis curvature begins. The shorter rules may be flexible andsurround the body of the penis and optionally serve as a guide to drawsuch lines around the whole penis.

It is also possible to use two such devices in parallel, associated inany way known by the one skilled in the art, in support to the methodsof the invention.

All rules and component parts of the auxiliary device of the inventioncan contain measurement marks, such as milimeter marks or guiding marksfor angles. Particularly, the device is disposable.

The auxiliary device of the invention can be of any material, such asmetal, polymers, composites, etc. In a preferential embodiment, themetal is a stainless steel alloy 18Cr-8Ni.

The device of the invention is auxiliary to the method determine themain incision line, to the method determine the distribution and size ofthe forked ends of the main incision line, to the method determinedimensions of the defect as generated by the surgery to correct peniscurvature and its corresponding graft, and the surgical method tocorrect penis curvature, both to increase the short side and to reducethe long side of the penis.

SHORT DESCRIPTION OF DRAWINGS

The objects, improvements and effects of the methods and device of theinvention will be better understood from the description presentedbelow, with reference to the attached figures, given only as anillustration of a particular embodiment of the invention. Said figuresare schematic, with dimensions or proportions which may not correspondto reality, since they only aim to didactically illustrate theinvention, not imposing any limitations to its scope other than thoseincluded in the claims further below.

FIG. 1 is a representation of a penis having curvature to be surgicallycorrected;

FIG. 2 is a representation of location details for the incisions as perthe methods of the invention;

FIG. 3 is a schematic representation of the geometrical relationsobtained from the method of the invention;

FIG. 4 is a schematic representation of a graft with rectangular shape;

FIG. 5 is a schematic representation of a graft with trapezoidal shape;and

FIG. 6 is a representation of the auxiliary device to the methods of theinvention.

DETAILED DESCRIPTION OF THE FIGURES

FIG. 1 shows a penis (1) provided with ventral curvature (20), locatedbetween two substantially straight segments (25) and (30). The segment(25) starts at the base (3) of the penis (1) and the segment (30) endsat the glans (2). The working plan is the plan containing segments (25)and (30), i.e. as seen by an observer looking at FIG. 1 on the sheet ofpaper.

A first aspect of the invention refers to a method to accuratelydetermine the location of the main incision line in a surgery to correctpenis curvature. The several steps of this method will be detailed belowwith reference to the figures:

a. inducing and keeping the penis erect—an infusion pump, not shown, isused to obtain maximum erection of the penis (1);

b. determining a line along the central axis of the penis—this is line(6).

c. determining a tangential line to each one of the two substantiallystraight segments adjacent to the curvature (20)—these are lines (7) and(8), respectively tangential to the straight segments (25) and (30)crossing at the point (I). Said tangential lines can be determined atany point along the width of the penis over the working plan, e.g. asshown by lines (7′) and (8′) which are crossed at the point (I′).

d. determining the bisectrix at the intersection of said both tangentiallines—this is line (9), which is at the average angle between bothtangents (7) and (8), or (7′) and (8′), including the point (I) or (I′).

e. determining the main incision line, whose direction coincides withthe bisectrix direction—the circumference line (12) shows the directionof the main incision on FIG. 1.

The surgeon can draw all lines mentioned in the method, or how many heor she wishes, since they only serve as a support for the accuratedetermination of the main incision line.

Another particular aspect of the invention is a method to accuratelydetermine the geometrical distribution and size of the forked ends ofsaid main incision line, comprising steps (a) to (e) of the describedmethod and, including the following steps:

f. determining two perpendicular lines (10) and (11) respectively tosaid tangential lines (7) and (8), or (7′) and (8′)—see FIG. 1. Lines(10) and (11) pass respectively through points (P) and (Q), which arethe nearest points to the curvature (20), i.e. they pass through thepoints where tangential lines (7′) and (8′) start to separate from lines(4) of the penis (1) surface, no longer coinciding with them.Corresponding points are determined when tangents (7) and (8) getfarther from the central penis axis (6). Other pairs of perpendicularlines such as (10′) and (11′), farther from the curvature (20), areperfectly acceptable, as well as (10) and (11′), or (10′) and (11), aslong as they are taken and kept as standards for the following step.

g. determining the difference (C) (concerning the curvature (20))between the extension (A) of the longer side and the extension (B) ofthe shorter side of the penis, between said perpendicular lines (10) and(11), over the working plan, as seen on FIG. 1. The difference (C) canbe visually obtained as shown on FIG. 3. As stated, if the adoptedperpendicular lines were e.g. (10′) and (11′), the difference (C) wouldbe calculated by taking the extension from the longer side between lines(10′) and (11′) and mandatorily the extension of the shorter side wouldalso be measured between lines (10′) and (11′).

h. determining a perpendicular line to the main incision line, crossingit at a point (G), with the same length of said difference (C), withends (F) and (F′), equally distant from the bisectrix 9—this means todetermine a line (15) crosswise to the main incision line (12), passingthrough the point (G) (or (G′) at the opposed end) with length equal tosaid difference (C), with ends (F) and (F′) (or (F″) and (F′″) at theopposed end) equally distant from the point (G) (or (G′)) of the mainincision line (12). Therefore, on line (15), the distance between (F)and (G) is equal to the distance between (F′) and (G), and is equal to(C)/2;

i. determining the dimension of a segment (S), so thatS=tg(90−(α/2).C/2

in which α is the desired angle between both ends on the fork at the end((E) or (E′)) of the main incision line (12) and (C) is the previouslymentioned difference.

j. Determining the location of a point (E) (or (E′) at the opposed end),distant from the point (G) (or the point (G′) at the opposed end), withthe value of extension of said segment (S) along the main incision line(12).

k. link the point (E) to the points (F) and (F′), so as to obtain thedistribution of the ends (14) and (14′) of the fork under the desiredgeometry, i.e. with an angle α between the ends (14) and (14′) with asize determined by the distance between points (E) and (F), or (E) and(F′) (or even (E′)-(F″) or (E′)-(F′″), at the opposed end of line (12)).

Particularly, points (E) and (E′) of the main incision line (12) arelocated on the longer side (4) or with longer curvature (20) of thepenis.

The determination of the length of the segment (S) is based ontrigonometry. We can see on FIG. 2 that, in the triangle formed by thesides (14), (S) and segment F-G of line (15):

-   -   the sum of the internal angles of the triangle is β+α/2+90=180,        therefore        β=90−α/2;    -   the tangent to the angle β is equal to the ratio between (S) and        (C)/2 dimensions (opposed cathetus to adjacent cathetus).

Joining these two equations and isolating (S), we reach:S=tg(90−(α/2).C/2

By way of a typical embodiment, adopting α=120°, (S) will be equal toC/4.

One further aspect of the invention consists of a method determine thedimensions of a defect to be filled in by a graft, when the elongationof the short side of the penis is desired for the surgery to correctcurvature. To obtain a rectangular defect, the method basicallycomprises the steps of:

a. determining the extension of the main incision line (12) betweenpoints (G) and (G′), representing the length (L) of said defect, asshown on FIG. 4.

b. determining the difference (C) between the extension (A) of thelonger side and the extension (B) of the shorter side of the penis,between said perpendicular lines ((10) and (11)), over the working plan;with the difference (C) representing the width of said defect, as shownon FIG. 4 Check if the vertexes of the defect are the points (F), (F′),(F″), (F′″).

c. proportionally increase, be it the case, the length and widthmeasurements of the defect, from the steps (a) and (b) above, with thegraft material to be used if it presents contraction. e.g. bovinepericardium is not subject to substantial contraction, as opposed todermis.

d. transporting and drafting the length and width measurements of thedefect, from the steps (a) and (b) above, with the optional correctionof item (c) over the graft material.

To obtain a trapezoidal defect which is appropriate for lateralcorrection cases, or with predominantly lateral curvature, the methodbasically comprises the steps (a) and (b) above, along with thefollowing:

c. determining the dimension of the shorter base of the trapeziumbetween about 10% and about 50% of the value (C) a value (X), obtainingthe dimension (D), from FIG. 5.

d. to obtain the dimension of the longer base of the trapezium, (C) issummed to (D), see FIG. 5.

e. proportionally increasing, be it the case, the measurements fromsteps (a), (c) and (d) above if the graft material to be used iscontracted;

f. transport the measurements from steps (a), (c) and (d), respectivelydefining height, shorter base and longer base of the trapezoidal shapeof the generated defect, with the optional correction of step (e) overthe graft material.

In the cases of creation of a defect for lateral or predominantlylateral curvatures, the distribution and dimensions of the forked endsare proportionally changed, bearing in mind the trigonometric relationand applied on items (i), (j) and (k) of the method as described furtherback.

In FIG. 6, one more aspect of the invention is illustrated, i.e. anauxiliary device (21) to the realization of the above described methods.

Said device (21) comprises (a few references shown on FIGS. 1 and 2 aremade):

a. two longer rules (22) and (23) linked together by a junction (26) andadjustable between them along a hypothetical plan containing them,having rotation and/or translation between one and the other;

b. a flexible measurement element (24) connected to said junction (26)of the two longer rules (22) and (23);

c. two shorter rules (28), (29), each one respectively fixed (32) to oneof said longer rules (22), (23), perpendicularly to them, which are ableto move in translation along their lengths.

d. optionally, elements to non-permanently clamp the device to the penisor to portions of it (not shown), e.g. clamps or staples.

In the illustration of a particular embodiment of the device (21) of theinvention as per FIG. 6, the longer rules (22), (23) are provided withtrails (20), (31) allowing the translation movement of one with relationto the other one. The longer rules permit the determination e.g. of thecentral penis axis (6) and the tangential lines (7′) and (8′), whiletrail openings can be used to guide and allow to draw said lines.

Shorter rules (28), (29) are used in the determination of perpendicularlines (10) and (11). They move in this case along said trails (20), (31)of the longer rules (22), (23), keeping position perpendicular to them.

The measurement element (24) is also provided with a trail or tear (35)which is used by the surgeon to determine the bisectrix line (9) guidingthe main incision line (12). Being flexible, e.g. as a flexible plasticribbon, it can surround the body of the penis, facilitating the draftingof line (12). It is provided with an (X) wide tear to allow the drawingof line (12).

The measurement element (24) has rotation movement with relation to thelonger rules (22), (23) by means of a clamping (26) also joining it tothem. Said clamping means are provided with two concentric axes (26)and. (27), one linked to one of the longer rules (22), (23) and anotherone linked to the measurement element (24), provided with measurementmarks (not shown) allowing the verification of the angles, e.g. when themeasurement element is located over the mean angle position, i.e. overthe bisectrix (9) between the longer rules (22), (23).

It should be clear that, despite particular embodiments of the inventionhaving been described with regard to a penis having ventral curvature asshown by FIG. 1, the methods of the invention, eventually conjugatedwith the auxiliary device as described, may be employed to correctcurvatures of any kind, i.e. lateral, dorsal, ventral curvatures,besides the conjugation of two simultaneous curvatures, e.g. above andlateral, and also when there is more than one curvature on the samepenis.

It should be recognized that, although the invention was described withrelation to a few particular embodiments, the person skilled in the artis able to develop a wide variation of equivalent structural oroperational details, expanding the above shown methods and device forother purposes, but not deviating from the scope of the invention.Attached claims should be interpreted as covering all equivalentsfalling within the scope and character of the invention.

1. A method to determine the location of the main incision line in asurgery to correct penis curvature, said method comprising the steps of:a) inducing and keeping a penis erect; b) determining a line along acentral penis axis; c) determining a tangential line to each one of twosubstantially straight segments adjacent to a penis curvature to becorrected; d) determining a bisectrix on an intersection of said twotangential lines; and e) determining a main incision linecircumferential on a body of the penis, whose direction coincides with adirection of the bisectrix.
 2. The method according to claim 1, in whichthe penis is kept under maximum erection by means of a pump, whereinsaid pump is an infusion pump, continuously injecting saline solutioninto a corpora cavernosa of the penis.
 3. The method according to claim1, in which an extension of said main incision line is enough to fullybreak force lines present on a curved region of the penis to becorrected.
 4. The method according to claim 1, which is employed in acorrective surgery to increase a shorter side of the penis.
 5. Themethod according to claim 1, which is employed in a corrective surgeryto reduce a longer side of the penis.
 6. The method according to claim 1further comprising the steps of: f) determining two perpendicular linesrespectively to said tangential lines, each one over a straight segmentof the penis, so as not to cross the curved region; g) determining adifference between an extension of a first side and an extension of asecond side of the penis, between said two perpendicular lines, whereinsaid first side is a side of the penis longer than the second side; h)determining a perpendicular line to the main incision line, passing at aperpendicular line end point with the same length of said difference,with end points equally distant from the bisectrix; i) determining adimension of a segment, so that:S=tg(90−(α/2)·C/2 in which α is a desired angle between both ends on afork of the main incision line and (C) is the difference determined instep g); j) determining a location of a point, distant from theperpendicular line end point, with a value of extension of said segmentalong the main incision line; and k) linking said point to the endpoints, so to obtain a distribution of forked ends with a desiredgeometry, with angle α and a size determined by the distance betweenpoints.
 7. The method according to claim 6, in which a path of said mainincision line is such not to cross both insertions of an intracavernosumseptum.
 8. The method according to claim 6, in which said perpendicularlines are drafted passing through points where said line of the centralpenis axis starts to get farther from said tangential lines no longercoinciding with them.
 9. The method according to claim 6, in which saidperpendicular lines are drafted as passing through any point of thecentral penis axis which is not over the curved region of the penis. 10.The method according to claim 6, in which the angle α is between 60° and180°, particularly between 90° and 150°, more particularly about 120°.11. The method according to claim 6, which is employed in a correctivesurgery to increase the second side of the penis.
 12. The methodaccording to claim 6 further comprising the steps of: l) determining anextension at the main incision line between the perpendicular line endpoint; m) obtaining dimensions of a rectangular defect, wherein theextension represents a height of the rectangular defect and thedifference represents a width of the rectangular defect; and n)obtaining dimensions of a trapezoidal defect, wherein the extensionrepresents a height of the trapezoidal defect, wherein a dimension of ashorter base of the trapezium is between 10% and 50% of the differencevalue and a dimension of a longer base of the trapezium is between 110%and 150% of the difference value.
 13. The method according to claim 12further comprising the steps of: o) proportionally increase themeasurements from step m) in case of a rectangular defect, or themeasurements from step n) in case of a trapezoidal defect, for the useof grafting material subject to contraction; and p) transport and drawthe dimensions obtained in steps m) or n) over the grafting material,with a correction of contraction of the grafting material.
 14. A methodto correct penis curvature, said method comprising the steps of: a)geometrically determining a location of a main incision line crosswiseto a central penis axis, so that it is located over a maximum curvedregion to be corrected; b) correcting the curvature by increasing ashorter side of the penis: b1) geometrically determining a desireddistribution and size of forked ends of a main incision line; b2)geometrically determining a size of a defect created by an incision onthe main incision line and the forked ends; b3) effecting the mainincision and the incision of the forked ends, generating a defect; b4)introducing a graft over said defect, substantially coincident with thedefect, with corrected dimensions corresponding to a contraction of agrafting material of the graft; and c) correcting the curvature byreducing a longer side of the penis, the longer side is reduced by avalue between an extension of the longer side and an extension of theshorter side of the penis in the curvature region by means of one ormore of the following skills selected from the group consisting ofplication, pleat, excision and suture, and lengthwise incision andcrosswise suture.
 15. The method according to claim 14, which uses anyapplication of said skills over one or more places inside the curvatureregion, as long as the total reduction is an extension of the value.